S-Caine™ Peel (Skin Numbing Cream) to Treat Pain During Pulsed Dye Laser (PDL) Therapy in Adults

Pain Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo Controlled, Parallel Study Evaluating the Efficacy of S-Caine™ Peel (Lidocaine 7% and Tetracaine 7% Cream) to Provide Local Dermal Anesthesia for Pulsed Dye Laser Therapy in Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00110773
• Other study ID #: SCP-42-05
• Status: Completed
• Phase: Phase 3
• First received: May 12, 2005
• Last updated: June 4, 2012
• Start date: June 2005
• Est. completion date: October 2005

Study information

• Verified date: June 2012
• Source: ZARS Pharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Pulsed dye laser (PDL) on the face is painful. For this reason, local anesthesia is commonly used to eliminate or minimize the pain. S-Caine™ Peel (lidocaine 7% and tetracaine 7% cream) is a eutectic formulation of lidocaine and tetracaine. The purpose of this study is to evaluate the efficacy of S-Caine Peel for induction of local dermal anesthesia for PDL therapy in adults.

Description:

This was a multi-center (5 centers), double-blind, placebo-controlled, parallel study that included 80 adults who met all the eligibility criteria and who were undergoing PDL therapy for the treatment of vascular lesions on the face.

During the screening visit, the study, including potential risks and benefits, was clearly explained to each patient, and written informed consent was obtained from each patient. The screening visit also included: evaluating eligibility criteria, obtaining a medical history (including skin type, demographic data, and concomitant medications), a brief physical examination, and a urine pregnancy test (for women of childbearing potential). The screening visit could be completed on the same day as the procedure visit.

At the procedure visit, eligible patients were assigned the next available sequential patient number. By having a patient number assigned to them, patients were randomized to receive S-Caine Peel or placebo on the facial treatment area.

The surface area of the intended treatment area was determined (up to 200 cm2). A thin layer (approximately 1 mm or the thickness of a dime) of the study drug was applied evenly across the area to be treated. The study drug was applied for 20 minutes (±2 minutes).

Immediately following removal of the study drug, the investigator performed an evaluation of skin reactions, assessing the treatment area for erythema, edema and blanching or any other adverse skin reaction.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 2005
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient is 18 years of age or older

• Patient elects to undergo PDL therapy for the treatment of vascular lesions on the face

Exclusion Criteria:

• Patient is pregnant or breastfeeding

• Patient has participated in a clinical trial of an unapproved drug within the previous 30 days

• Patient has participated in any clinical trial involving S-Caine Peel

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• S-Caine™ Peel (lidocaine and tetracaine topical cream 7%/7%)
S-Caine Peel, composed of a 1:1 (w:w) eutectic mixture of 7% lidocaine and 7% tetracaine, applied topically. S-Caine Peel applied at approximately 1 mm in thickness and remained on the treatment area for 20 minutes (±2 minutes).
• Placebo Peel
Placebo Peel applied topically at approximately 1 mm in thickness and remained on the treatment area for 20 minutes (±2 minutes).

Locations

Country	Name	City	State
United States	Midwest Cutaneous Research	Clinton Township	Michigan
United States	Laser and Skin Surgery Center of New York	New York	New York
United States	Washington Institute of Dermatologic Laser Surgery	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
ZARS Pharma Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Intensity	Patient's evaluation of procedural pain intensity using the 100 mm Visual Analog Scale (VAS).	20 minutes	No
Secondary	Number of participants with adverse events	To monitor the nature and frequency of adverse events (AEs) associated with the application of S-Caine Peel	20 minutes	Yes